The present invention generally relates to the field of vascular closure devices. More specifically, this invention may be used to close openings in the vasculature created to perform intravascular procedures. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein.
A variety of procedures are currently performed which access various portions of the human body through the vasculature. These procedures are begun by puncturing the skin and providing access into an artery or vein. Access to the artery may be provided by cutting open a portion of the body and exposing the artery. That artery may then be accessed by puncturing the artery. Alternatively, access to the artery may be gained by a technique commonly known as the Seldinger technique. Seldinger invented a system which includes a needle, sheath and dilator to provide a resealable access point into the vasculature. Common points of vascular access include the brachial artery accessed just above the elbow, the radial artery approach accessed just above the wrist, or the femoral artery approach accessed just below the groin.
One of the most common procedures is balloon angioplasty. Balloon angioplasty is typically performed through a sheath placed in a vascular access point. After a sheath is firmly located in the vascular access point, a guide catheter is inserted through the sheath and into the vascular system. The guide catheter is then typically advanced under fluoroscopy to the ostium of the left or right coronary artery.
After the distal end of the guide catheter is satisfactorily located in the ostium of a coronary artery, a guide wire is inserted through the sheath, inside the guide catheter and advanced through the guide catheter until the distal end of the guide wire emerges from the distal end of the guide catheter. The guide wire is further advanced through the coronary vasculature until it reaches a portion of vasculature which is in need of treatment. Commonly, the vasculature will be partially or completely obstructed by stenotic material which may be comprised of plaque or other material. Typically the distal end of the guide wire is advanced beyond the area of treatment.
After the guide wire is located in a desired position, a balloon catheter is inserted into the sheath. The balloon catheter is threaded over the guide wire and inside the guide catheter. The distal end of the balloon catheter is advanced to the treatment site and located such that the balloon is positioned within the stenosis. Once the balloon is in position it is inflated with fluid and thereby expanded. Expansion of the balloon forces any stenotic material away from the center of the blood vessel and thereby improves the patency of the artery which is being treated. Once dilatation is complete, the balloon catheter is removed.
This procedure may be repeated with different size balloons or in multiple sits within the vasculature depending upon patient need. However, once the procedure is complete, the physician will remove the balloon catheter, guide wire, guide catheter and ultimately the sheath itself. Sheaths may range in size from 4-9 French. Depending upon the size of the sheath, a relatively large hole has been made in the artery at the vascular access site. Without further treatment, the patient would likely bleed to death through the hole made when the sheath is removed.
There are several methods of treating the vascular wound once the sheath has been removed. The most common method of treatment is simple pressure. This method may include a pressure dressing, physical pressure applied by an attendant, or pressure applied by some sort of apparatus. While this method is ultimately effective, it may take several hours to safely close the vascular access site such that the patient is able to move about.
Alternative systems to pressure have also been developed. These systems commonly known include heat sealing, lasers, suture based systems, or various types of plugs or glues. Plugs may be made in many different shapes and may be created from a variety of materials. No matter what the material or the shape of the plug, accurate placement of the plug is desirable. Placement is particularly import with prior art plug systems which use some portion of the patient""s blood to form a clot or other obstructions. Prior art closure systems such as U.S. Pat. No. 5,626,601 to Gershoney. This particular system uses a balloon which can be inflated to prevent the closure material from entering the vessel. Once the plug material has been injected into the vascular access site and partially solidifies, the balloon is deflated and pulled through the plug material. Another prior art closure invented by Kensey and described in U.S. Pat. No. 5,676,689, uses a biodegradable backstop to prevent a plug from entering the vessel. This backstop is left in the vessel until it eventually degrades. While many systems exist, a system which provides better placement of the plug material may be desirable.
While one particular vascular procedure has been described as background, one skilled in the art will appreciate that the inventive technique may be used for any variety of intravascular or other intra-body access procedures known in the art.
The present invention overcomes the deficiencies of the prior art by providing a method to safely deliver a closure system without the use of prior art protection devices the patient.